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# QSR

Quality System Regulation (21 CFR 820)

Definition

FDA's current Good Manufacturing Practice requirements for medical devices, covering design controls, CAPA, document control, and production. Being replaced by QMSR in February 2026.

More in FDA

[524B](/glossary/524b)[RTA](/glossary/rta)[eSTAR](/glossary/estar)[TPLC](/glossary/tplc)[PMA](/glossary/pma)[510(k)](/glossary/510k)

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